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Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension

Primary Purpose

Hypertension

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

stereotactic body radiotherapy (SBRT)

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 55 and ≤ 75 years. Systolic blood pressure of 160 mmHg or greater despite being treated with at least three hypertensive drugs for more than 3 months.

Exclusion Criteria:

GFR < 45 ml/min/1.73 m2. Known causes of secondary hypertension. Hospitalized for hypertensive crisis within 1 year. History of acute coronary syndrome or cerebrovascular accident within the last 6 months.

Pregnancy or have a pregnancy plan. Contrast media or iodine allergy. History of abdominal radiotherapy or adhesive intestinal obstruction. Severe valvular heart disease. Stenosis >50% or renal artery aneurysm in either renal artery. Others.

Sites / Locations

Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

stereotactic body radiotherapy (SBRT)

Arm Description

Noninvasive SBRT will be delivered in a single fraction to bilateral renal arteries determined by CT-guidance.

Outcomes

Primary Outcome Measures

Safety Endpoint

Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria that are related to the procedure.

Ambulatory Blood Pressure Reduction

Mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment

Secondary Outcome Measures

Office Blood Pressure Reduction

Mean reduction in office blood pressure at 90 days post-treatment

Number of Drug Adjustments

Number of drug adjustments for hypertension through 90 days after treatment

Full Information

NCT ID

NCT04198155

First Posted

December 11, 2019

Last Updated

December 11, 2019

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT04198155

Brief Title

Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension

Official Title

Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

December 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 2020 (Anticipated)

Primary Completion Date

September 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study is conducted to investigate the short-term safety and preliminary efficacy of stereotactic radiotherapy for renal denervation to treat refractory hypertension.

Detailed Description

This will be a single centre, single arm, prospective cohort study. Patients with refractory hypertension will receive single fraction stereotactic radiotherapy for renal denervation. The study has been designed in a careful and stepwise dose escalation fashion in order to minimize the potential risks associated with this innovative technique. The dose escalation is guided by 3+3 algorithm to ensure more patients will be spared dose limiting toxicities and more patients will be entered on the dose level that will be chosen as optimal dose of maximal effect. Low dosing levels with established safety profile will first be applied before administering higher dosing levels based on preclinical studies. Safety is the primary endpoint of this study. Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria associated with the procedure through 90 days. Efficacy will be evaluated by assessing mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

stereotactic body radiotherapy (SBRT)

Arm Type

Experimental

Arm Description

Noninvasive SBRT will be delivered in a single fraction to bilateral renal arteries determined by CT-guidance.

Intervention Type

Radiation

Intervention Name(s)

stereotactic body radiotherapy (SBRT)

Intervention Description

Image-guided stereotactic body radiation therapy

Primary Outcome Measure Information:

Title

Safety Endpoint

Description

Safety will be assessed by incidence and evaluation of any serious adverse events using CTCAE v5.0 criteria that are related to the procedure.

Time Frame

90 days

Title

Ambulatory Blood Pressure Reduction

Description

Mean reduction in average 24-hour ambulatory blood pressure at 90 days post-treatment

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Office Blood Pressure Reduction

Description

Mean reduction in office blood pressure at 90 days post-treatment

Time Frame

90 days

Title

Number of Drug Adjustments

Description

Number of drug adjustments for hypertension through 90 days after treatment

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 55 and ≤ 75 years. Systolic blood pressure of 160 mmHg or greater despite being treated with at least three hypertensive drugs for more than 3 months. Exclusion Criteria: GFR < 45 ml/min/1.73 m2. Known causes of secondary hypertension. Hospitalized for hypertensive crisis within 1 year. History of acute coronary syndrome or cerebrovascular accident within the last 6 months. Pregnancy or have a pregnancy plan. Contrast media or iodine allergy. History of abdominal radiotherapy or adhesive intestinal obstruction. Severe valvular heart disease. Stenosis >50% or renal artery aneurysm in either renal artery. Others.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yi-Gang Li, MD

Phone

86-13761318166

liyigang@xinhuamed.com.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Xingxing Cai, MD&PhD

Phone

86-18217730053

cxxdoc@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yi-Gang Li, MD

Organizational Affiliation

Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Xinhua Hospital, School of Medicine, Shanghai Jiao Tong University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200092

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Renal Denervation Using Stereotactic Radiotherapy System for the Treatment of Refractory Hypertension

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